FDA Adverse Event
Injury
Summary report: N
MEDTRONIC
MDR report key: 753845
·
Received August 9, 2006
Report
- Report Number
- MW1040001
- Event Type
- Injury
- Date Received
- August 9, 2006
- Date of Event
- July 12, 2006
- Report Date
- August 8, 2006
- Manufacturer
- MEDTRONIC
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
APPARENT LEAD FRACTURE AND MULTIPLE SHOCKS. PT CAME IN W/OVERSENSING OF RV LEAD. LEAD REVISION THE NEXT DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC | * | LWS | MEDTRONIC | 6949 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention |